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Reanny Medical Devices Management Consulting Co., Ltd.

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020-82513196

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Congratulations to Dongguan Jingfeng Precision Company for passing the FDA factory inspection

Dongguan Jingfeng Precision Electronics Co., Ltd. is a professional manufacturer of various active dental medical equipment products such as dental photopolymerization, high/low speed mobile phones, polishing motors, etc.

The company was established in 2015 and has CNC, post-processing, assembly, and sandblasting processes.

After signing the cooperation agreement, our company tailored a consulting plan based on the actual situation of the client. In the process of coaching, we conduct training, program revision review, document and record creation coaching and review module by module.
Due to the poor foundation of the client, in order to achieve the goal of approval, we have exceeded the contract period by more than a week to continue providing coaching to the client.

The auditor is a South American FDA auditor with 25 years of experience in factory inspection and auditing, and a deep understanding of Chinese culture.
The audit is divided into the following itinerary:
1) Factory inspection
2) CAPA: CAPA cases, feedback, complaints NCARS
3) Special Process Confirmation
4) Design and development
5) Supplier file review
6) DHR and Inspection Test Procedure
7) Instrument calibration

With careful preparation in the early stage and timely response and handling on site, the factory passed the FDA factory inspection smoothly after a four-day audit.
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020-82513196

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